A Prospective Natural History Study in Uveal Melanoma
The overall objective of this proposal is to develop and utilize a multicenter UM registry that will, in a longitudinal fashion, capture prospective data in order to characterize the natural history of UM and provide data that will be used to support the development of novel therapies for this disease. The care of patients with UM requires a multi-disciplinary team of physicians that commonly requires the involvement of both radiation oncology and interventional radiology, and is typically directed by an ophthalmologic oncologist at time of initial diagnosis of primary disease. Overall management is transitioned to a medical oncologist when distant recurrence is identified. In the case that a patient presents with metastasis at the time of diagnosis, a medical oncologist typically directs overall management. The management of surveillance for the development of metastasis following the treatment of primary disease is variable and, if performed at all, is managed by either an ophthalmologic oncologist or medical oncologist. Thus, the successful development of a registry that aims to capture the data regarding the full natural history of UM requires a collaborative effort including leaders from both the UM ophthalmologic oncology and medical oncology fields. To this end, the investigators have built an initial consortium of key ophthalmologic oncology and medical oncology leaders from multiple major UM centers in the United States.
Conditions:
🦠 Uveal Melanoma
🗓️ Study Start (Actual) 6 May 2021
🗓️ Primary Completion (Estimated) July 2026
✅ Study Completion (Estimated) July 2026
👥 Enrollment (Estimated) 700
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States
📍 New York, New York, United States
📍 Philadelphia, Pennsylvania, United States
📍 Houston, Texas, United States
📍 Adelaide, Australia
📍 Chatswood, Australia
📍 East Melbourne, Australia
📍 Maribyrnong, Australia
📍 North Adelaide, Australia
📍 Subiaco, Australia
📍 Sydney, Australia
📍 Sydney, Australia
📍 Toronto, Canada
📍 Erlangen, Germany
📍 Birkenhead, United Kingdom
📍 Northwood, United Kingdom
📍 Sheffield, United Kingdom

📋 Eligibility Criteria

Description

  • Inclusion Criteria
  • * Diagnosis of uveal melanoma
  • * Ability to provide written informed consent for participation in the prospective registry OR an institutional waiver by the IRB/ethics committee for retrospective data collection without written informed consent
  • Exclusion Criteria
  • \*None
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 July 2020
  • First Submitted that Met QC Criteria 13 October 2020
  • First Posted 19 October 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 July 2024
  • Last Update Posted 12 July 2024
  • Last Verified July 2024